Regulatory Affairs Specialist/Manager

3Shape is changing dentistry together with dental professionals across the world by developing innovations that provide superior dental care for patients. Our portfolio of 3D scanners and CAD/CAM software solutions for the dental industry includes the multiple award-winning 3Shape TRIOS intraoral scanner, the upcoming 3Shape X1 CBCT scanner, and market leading scanning and design software solutions for dental labs.

Responsibility:

·        Provide the Regulatory Affairs department with country specific regulatory input supporting product development and product lifecycle management

·        Ensure regulatory approval and maintenance of products (active devices and software as a medical device) and in collaboration with regulatory consultants, if relevant

·        Review product and packaging labels, IFUs, marketing material

·        Answer questions from Competent Authorities concerning regulatory topics in collaboration with Regulatory Affairs department  and/or regulatory consultants, if relevant.

·        Responsible for communication with Competent Authorities with regard to vigilance cases, recalls and FSNs in collaboration Regulatory Affairs department and/or regulatory consultant, if relevant

·        Communication with customers regarding regulatory issues

·        Ensure that the company's policies, procedures and operating guidelines conform to country specific laws, regulations and industry practices.

·        Responsible for the daily collaboration with regulatory consultants as well as evaluation of performance and costs.

·        If decided, establish and maintain procedures required for local 3Shape entity to act as Marketing Authroisation holder

·        Act as qualified person for local 3Shape office, if required by Competent Authority

·        Act as QMS Management Representative, if required by Competent Authority

·        Act as local responsible person for post-market surveillance activities, if required by Competent Authority

Requiremnets:

·        Eudcation: Relevant technical, engineering or natural science  background, preferably a university degree

·        Experience with regulatory affairs from a medical device company, preferably with active devices and/or software devices

·        Familiar with country specific Medical Device regulation (PMDA, KFDA, ANVISA, CFDA) as well as ISO13485, ISO 62304, Low Voltage Directive and EMC Directive etc.

·        Excellent planning, cooperation, and communication skills

·        Fluent in English with excellent verbal and written communication skills

Application deadline

asap

Location

Shanghai, China

Send application

http://www.3shape.com

About Us

3Shape is changing dentistry together with dental professionals across the world by developing innovations that provide superior dental care for patients. Our portfolio of 3D scanners and CAD/CAM software solutions for the dental industry includes the multiple award-winning 3Shape TRIOS intraoral scanner, the upcoming 3Shape X1 CBCT scanner, and market leading scanning and design software solutions for dental labs.
Two graduate students founded 3Shape in Denmark’s capital in the year 2000. Today, 3Shape has over 1,500 employees serving customers in over 100 countries from an ever-growing number of 3Shape offices around the world. 3Shape’s products and innovations continue to challenge traditional methods, enabling dental professionals to treat more patients more effectively. www.3shape.com

Working at 3Shape

Become part of an international success, financially as well as product wise. As an employee, you have plenty of room to both make a difference and fulfil personal ambitions in a very knowledge intensive and challenging environment.

3Shape Technology

Through the relentless drive for new digital innovation by 3Shape, we claim to be the most extensive and versatile CAD/CAM system on the market.

3Shape - a Global Company

3Shape is headquartered in Copenhagen, with development teams in Denmark as well as in the Ukraine and with a production site in Poland. 3Shape is a global company with presence in Europe, Asia and the Americas.

Our People

Employing and developing the right people is an important key to 3Shape's success. We want to be the best within our business, an ambition which has created a true fighting spirit throughout the company - with lots of commitment and courage, and a professional attitude towards business.